Clinical Validation of iCare IC1000 Tonometer

Not Applicable

Not yet recruiting

• Conditions: Intraocular Pressure

• Registration Number: NCT06748092
• Lead Sponsor: Icare Finland Oy

Brief Summary

Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-04-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Age ≥ 18 years

Exclusion Criteria

• Subjects with only one functional eye
• Subjects having poor or eccentric fixation in the study eye
• High corneal astigmatism >3D in the study eye
• Central corneal scarring
• History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
• Microphthalmos
• Buphthalmos
• Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
• Dry eyes (clinically significant)
• Lid squeezers - blepharospasm
• Nystagmus
• Keratoconus
• Any other corneal or conjunctival pathology or infection relevant to this study
• Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
• Cataract Extraction within last 2 months in the study eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers	Through study completion, an average of 6 months	Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.

Secondary Outcome Measures

Name	Time	Method
Retrospective analysis of "Quick Measure" mode	Through study completion, an average of 6 months	The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure.

Trial Locations

Locations (1)

Nova Scotia Health/Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada